A Single-Center, Randomized, Double-Masked, Placebo and Active Controlled, Dose-Ranging Evaluation of the Duration of Action of Brimonidine Tartrate Ophthalmic Solution in the Control of Ocular Redness Induced by Conjunctival Allergen Challenge (CAC)

The purpose of this study is to evaluate the safety, efficacy, and dose response of brimonidine tartrate ophthalmic solution as compared to placebo in the prevention of allergen-induced conjunctival redness using a conjunctival allergen challenge (CAC) model.

It is hypothesized that low-dose brimonidine tartrate ophthalmic solution will be more effective than vehicle in the prevention of conjunctival redness induced by conjunctival allergen challenge when instilled prior to the allergen challenge.

Study Overview

• Status: Completed
• Conditions: Allergic Conjunctivitis
• Intervention / Treatment: Drug: Vehicle; Drug: Brimonidine Tartrate 0.01%; Drug: Oxymetazoline HCl 0.025%; Drug: Brimonidine Tartrate 0.025%

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • ORA, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Be at least 18 years of age;
• If female, cannot be not pregnant or nursing
• Have a positive skin test reaction to cat hair, cat dander, grasses, ragweed, dog dander, cockroach, dust mite, and/or trees within the past 24 months;
• Have a calculated best corrected visual acuity of 0.6 logMAR or better in each eye as measured using an ETDRS chart;

Exclusion Criteria:

• Have known contraindications or sensitivities to the use of any of the study medications(s) or their components;
• Have any ocular condition that, in the opinion of the investigator, could affect the subject's safety;
• Have a presence of active ocular infection;
• Use specified disallowed medications during the study or appropriate pre-study washout period;
• Have any significant illness;
• Have planned surgery (ocular or systemic) during the trial period or within 30 days after;
• Have used an investigational drug or device within 30 days of the study or be concurrently enrolled in another investigational drug or device study within 30 days of the study;
• Be a female who is currently pregnant or nursing.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Brimonidine Tartrate 0.025%	Drug: Brimonidine Tartrate 0.025%; one drop in each eye at designated visits
Other: Vehicle	Drug: Vehicle; one drop in each eye at designated visits
Active Comparator: Brimonidine Tartrate 0.01%	Drug: Brimonidine Tartrate 0.01%; one drop in each eye at designated visits
Active Comparator: Oxymetazoline HCl 0.025%	Drug: Oxymetazoline HCl 0.025%; one drop in each eye at designated visits

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Conjunctival Redness	at specified timepoints for up to 30 minutes

Collaborators and Investigators

• Sponsor: Eye Therapies, LLC
• Collaborators: ORA, Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: January 10, 2011
• First Submitted That Met QC Criteria: January 11, 2011
• First Posted (Estimate): January 12, 2011

Study Record Updates

• Last Update Posted (Estimate): March 6, 2012
• Last Update Submitted That Met QC Criteria: March 2, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Eye Diseases; Hypersensitivity; Conjunctival Diseases; Conjunctivitis; Conjunctivitis, Allergic; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Cardiotonic Agents; Respiratory System Agents; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Nasal Decongestants; Adrenergic alpha-1 Receptor Agonists; Brimonidine Tartrate; Phenylephrine; Oxymetazoline
• Other Study ID Numbers: 10-100-0008